Rheumatoid Arthritis Clinical Trial
Official title:
Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.
The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.
Detail protocol:
Selection and inclusion of patients will be done by principal investigator of Rheumatology
Department. After verification of inclusion and non-inclusion criteria by principal
investigator and signature of consent, patients will be randomized by 1: 1 randomization
(centralized randomization by statistician into 2 groups at Month 0). They will participate
in sessions in a deferred manner due to two per week for each group:
- Interventional "A" group: 32 sessions (on average 2/week) performed from Month 0 to
Month 4 in 15 patients.
- Control "B" group: 16 sessions (on average 2/week) performed from Month 2 to Month 4 in
15 patients.
Patients of "B" group will be not performing sessions with "A" group patients. Sessions
lasting about 45 minutes will be proposed from Monday to Friday in a room planned from this
activity within the CHU. Exercises will be adapted and personalized according to each one.
Evaluations will be carried out for group 1 (interventional) before the first session of tai
chi at Month 0, before the session at Month 2 and at the end of the protocol at Month 4. The
same evaluations will be carried out for group B (control) at Month 0, before first session
of tai chi at Month 2 and at the end of the protocol.
Assessment of pain and stress will be done before and after each session. Final assessment
will be done at 4 months after randomization. Fitness assessment and tai chi sessions will be
conducted by APA student. Clinical examination of patient, installation and removal of cardio
frequency meter will be performed by nurse. Data entry will be done by Clinical Research
Associate of the Rheumatology Department. Statistical analysis will be carried out by
biostatistician affiliated to the study.
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